Specialized speculum set for pediatric gynecological examinations
The Kristeller speculum for children (70x15 mm) with holder (75x10 mm) according to Figure 0 is a surgical instrument set of CE class I according to ISO 13485:2016. Specifically developed for pediatric gynecology, the set enables gentle and precise examination of young patients.
Product Highlights:
✔ Certified according to ISO 13485:2016
✔ CE marking Class I (MDR 2017/745)
✔ Child-appropriate dimensions – 70x15 mm (speculum), 75x10 mm (holder)
✔ High-quality stainless steel 1.4021 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993 – for safe application
✔ Atraumatic edges – for maximum patient comfort
✔ Ergonomic handles – for precise handling
✔ Lightweight construction – optimally adapted to child anatomy
✔ Sterilizable – multiple times via steam, plasma or heat
✔ Robust construction – for long service life
Benefits of the Kristeller Speculum Set Fig. 0:
• Specifically dimensioned for pediatric applications
• Atraumatic design for maximum patient comfort
• Lightweight and precise handling
• Optimal visibility with minimal trauma
Areas of Application:
• Pediatric gynecological examinations
• Pediatric gynecological diagnostics
• Specialized pediatric procedures
• Adolescent gynecology
Technical Specifications:
• Set: Kristeller Speculum with Holder
• Speculum: 70 mm length, 15 mm width
• Holder: 75 mm length, 10 mm width
• Configuration: Figure 0
• Material: Surgical Steel 1.4021
• Type: Reusable (multiple use)
• Mechanism: Precision guidance
• Risk Class: I according to MDR 2017/745
• Sterilization: Sterilizable (steam, plasma, heat)
Important Safety Information:
• For use by personnel trained in pediatric gynecology only
• Special care and sensitivity required during application
• Inspect for damage before each use
• Adhere to correct sterilization procedures
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